Clinical-stage biopharmaceutical company Dimerix (ASX: DXB) received an operational boost earlier today after announcing that patients from phase 2 trials will continue treatment with its DMX-200 adjunct therapy under Australia’s Therapeutic Goods Administration’s compassionate use special access scheme (SAS).
In the phase 2 clinical trials, patients suffering from diabetic kidney disease and focal segmental glomerulosclerosis (FSGS) are being treated with DMX-200, with clinical evidence indicating the drug may be of benefit.
The patients that will continue under the TGA’s SAS are in addition to patients who are already being treated via the same scheme after completion of a phase 2 trial in 2017 using DMX-200.
Recognising there can be circumstances patients need access to therapeutic treatments that are not listed on the Australian Register of Therapeutic Goods (ARTG), the TGA’s SAS enables physicians to prescribe medicines not yet approved in Australia.
These arrangements are made for individual patients, on a case by case basis under the scheme.
“The TGA approved the SAS Category B applications based on the safety profile of DMX-200, as well as clinical evidence that DMX-200 may benefit patients”, the company said.
“We are very happy to support the medical professionals and patients seeking treatment for their disease and who have very few medical options,” said Dr Nina Webster, chief executive officer and managing director of Dimerix.
Clinical studies report
Dimerix completed recruitment for a phase 2 diabetic kidney disease study in September 2019.
The study included a total of 45 patients to ensure “adequate statistical powering” and to pass minimum requirements.
Final dosing is scheduled for July 2020, with top-line data anticipated shortly thereafter, according to Dimerix.
Meanwhile, with respect to FSGS, Dimerix’s phase 2a study completed recruitment in July 2019, with the last patient dosed in September 2019 following final protocol screening.
Dimerix has stated that the study “remains on track” to complete final patient dosing in June 2020, with top-line data expected to be published thereafter.
Both trials were designed as double-blinded, placebo-controlled, cross-over studies whereby each patient receives both the drug and the placebo control for a defined period, in an unknown order, until the completion of the entire study.
With its phase 2 trials coming to an end in June and July respectively, Dimerix will report its top-line results later this year.
“The current blinded clinical studies are exploring the effect of DMX-200 over several months of treatment; however, it is pleasing that physicians have requested extended treatment of their patients with DMX-200,” Dr Webster noted.